Mgr, Drug Product Development & Manufacturing

Scorpion Therapeutics; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics is seeking a Manager, Drug Product Development and Manufacturing to oversee device combination drug product manufacturing at contract manufacturing organizations, ensuring quality and regulatory compliance. You will facilitate commercial manufacturing, conduct technical reviews, and collaborate with cross-functional teams (Supply Chain, Quality, Regulatory).

You will provide engineering input on device components, maintain documentation, support process validation, and

Qualifications

• Bachelor's degree in pharma sciences, engineering or chemistry.
• At least 4 years in development and commercialization of device combination products.
• Knowledge of device quality systems (21 CFR Part 820/4, ISO 13485).
• Familiar with risk management (ISO 14971) and GMP device manufacturing.
• Experience with human factors, dose delivery, container systems, extractables/leachables.
• Familiar with quality systems, SOPs and regulatory guidelines.
• Proficient in statistical analysis and technical documentation.

Responsibilities

• Facilitate commercial manufacturing, provide engineering oversight.
• Conduct technical reviews and collaborate with Supply Chain, Quality, Regulatory.
• Provide engineering expertise on device components.
• Maintain technical documentation and support process validation.
• Manage technical issues with device suppliers and ensure inspection readiness.

Skills

Statistical analysis

Technical documentation

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in Pharma Sciences, Engineering or Chemistry

Tools

Quality systems (GMP, ISO 13485)

Job description

Role:

Manager, Drug Product Development and Manufacturing, focused on support and oversight of device combination drug product manufacturing at CMOs.

Responsibilities:

facilitate commercial manufacturing, conduct technical reviews, collaborate with cross-functional teams (Supply Chain, Quality, Regulatory), provide engineering expertise on device components, maintain technical documentation, support process validation, manage technical issues with device suppliers, ensure compliance with regulatory and quality standards, and contribute to inspection readiness.

Requirements:

Bachelor's in Pharma Sciences, Engineering, or Chemistry; minimum 4 years' experience in development and commercialization of device combination products; knowledge of device quality systems (21 CFR Part 820/4, ISO 13485), risk management (ISO 14971), and GMP device manufacturing; experience with human factors, dose delivery, container systems, extractables/leachables; familiarity with quality systems, SOPs, and regulatory guidelines; proficiency in statistical analysis and technical documentation.

Preferred:

experience working with contract manufacturers, in a regulated environment, with multi-cultural teams; strong communication skills; travel up to 25%.

HighValue:

device combination products, commercial manufacturing, regulatory compliance, technical oversight, process validation, cross-disciplinary collaboration.

WorkSetup:

remote US-based with approximately 25% travel.